Effectiveness of a Non-invasive Therapy for Treating Fully Ruptured Anterior Cruciate Ligaments in the Knee by Using MRI, Functional Tests and Scores: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Knee function
研究概览
简要总结
The primary hypothesis is that Khalifa's therapy brings additional benefit compared to standard therapy (physiotherapy) for patients with a ruptured anterior cruciate ligament (ACL).
详细描述
Mohamed Khalifa, a therapist from Hallein (Austria), has been working since 30 years with a self-developed manual technique for treating injuries of the musculoskeletal system especially of the knee by applying high pressure to the skin in the area of the injury. This pressure is applied in various amplitudes and frequencies.
International top athletes from various disciplines reported a rapid pain relief, and even full recovery, immediately after his one hour treatment.
Prior to the investigators' study, the investigators evaluated one pilot patient with a complete ACL rupture after a soccer game with Magnet-Resonance-Imaging (MRI) and clinical tests. This patient was physically immobile and reported pain especially when stretching and bending the knee. After one hour of treatment from Khalifa the signs of the injury like the stretching / bending inhibition and pain were gone immediately. Three months after the treatment, an evaluation of the knee with MRI showed an end-to-end continuous ACL with homogeneous signal and the clinical tests confirmed the stability of the knee.
With this study the investigators will evaluate the possibility of influencing the healing of a completely ruptured ACL of the knee by one single special local pressure treatment to the skin for 60 min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •totally ruptured ACL - MRI verified, 4 weeks old as a maximum
- •knee function: Any functional inhibition (stretching, bending or load)
- •BMI: 18-28
- •athletically active
排除标准
- •any surgical procedures at the injured knee at any previous time
- •any acute surgical indication
- •diabetes mellitus and/or high blood pressure
- •any permanent drug treatment
结局指标
主要结局
Knee function
时间窗: 24 hours and 3 months after 1st therapy
IKDC-Score (International Knee Documentation Comite) clinical / physical examination KT-1000 evaluation
ACL Morphology
时间窗: 3 months after 1st therapy
Magnet resonance images: end-to-end homogeneous anterior cruciate ligament
次要结局
- Life Quality(24 hours, 3 months)
研究者
Andreas Sandner-Kiesling , MD
Univ.Prof.Dr.
Medical University of Graz
